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FDA 510(k)

Universal Cannula Seal (5-12 mm)

K-Number: K181395 · 2018-07-27

ApplicantIntuitive Surgical, Inc.
Decision Date2018-07-27
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Universal Cannula Seal (5-12 mm) is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2018-07-27 under 510(k) number K181395. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Universal Cannula Seal (5-12 mm)?

Universal Cannula Seal (5-12 mm) is a medical device that received FDA 510(k) clearance on 2018-07-27. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K181395.

When did Universal Cannula Seal (5-12 mm) receive FDA 510(k) clearance?

Universal Cannula Seal (5-12 mm) received FDA 510(k) clearance on 2018-07-27, under 510(k) number K181395.

Who is the listed applicant for Universal Cannula Seal (5-12 mm)?

The FDA 510(k) record lists Intuitive Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Universal Cannula Seal (5-12 mm)?

The FDA product code for Universal Cannula Seal (5-12 mm) is GCJ.

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Other records listing Intuitive Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253702Intuitive Endoluminal Gastrointestinal System (IG1000)K261824da Vinci Surgical System, Model IS5000K261249Universal Seal (5-12 mm)K260695da Vinci Firefly Imaging SystemK253986da Vinci Force Feedback InstrumentsK253978Universal Seal (5-12 mm)

View all 124 devices →

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.IncK261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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